US20020002390A1 - Implantable neurostimulator having a data communication link - Google Patents

Abstract

Disclosed is a multiple electrode, closed-loop, responsive system for the treatment of certain neurological diseases such as epilepsy, migraine headaches and Parkinson's disease. Brain electrodes would be placed in close proximity to the brain or deep within brain tissue. When a neurological event such as the onset of an epileptic seizure occurs, EEG signals from the electrodes are processed by signal conditioning means in a control module that can be placed beneath the patient's scalp, within the patient's chest, or situated externally on the patient. Neurological event detection means in the control module will then cause a response to be generated for stopping the neurological event. The response could be an electrical signal to brain electrodes or to electrodes located remotely in the patient's body. The response could also be the release of medication or the application of a sensory input such as sound, light or mechanical vibration or electrical stimulation of the skin. The response to the neurological event can originate from devices either internal or external to the patient. The system also has the capability for multi-channel recording of EEG related signals that occur both before and after the detection of a neurological event. Programmability of many different operating parameters of the system by means of external equipment provides adaptability for treating patients who manifest different symptoms and who respond differently to the response generated by the system.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present invention is a continuation of co-pending U.S. patent application Ser. No. 09/628,977, filed Aug. 2, 2000, which is a continuation of U.S. patent application Ser. No. 09/450,303, filed Nov. 29, 1999, now U.S. Pat. No. 6,128,538, which is in turn a continuation of U.S. patent application Ser. No. 08/957,869, filed Oct. 27, 1997, now U.S. Pat. No. 6,016,449.[0001]
FIELD OF THE INVENTION
• This invention is in the field of devices for the treatment of neurological disorders in human subjects, particularly those disorders that originate in the brain.[0002]
BACKGROUND OF THE INVENTION
• The current state of the art in treating neurological disorders such as epilepsy or Parkinson's disease involves either drugs or the open-loop electrical stimulation of neurologic tissue. Drug therapy has been shown to have significant short and long term side effects and is often ineffective. In U.S. Pat. No. 3,850,161, Liss describes a continuous closed-loop feedback system which will always feedback part of the brain EEG signal to separate electrodes so that if a large EEG signal occurs it will be fed back in an attempt to cancel out the original signal. This system does not take advantage of recently developed digital signal processing and microcomputer technology by which feedback signals can be activated only when a neurological event occurs, nor does it provide a practical means to recognize and intervene during early stages in the evolution of a neurological event. In addition, the Liss device is not programmable and it does not provide a means to record EEG signals. Examples of a “neurological event” are the occurrence of an epileptic seizure or the occurrence of a migraine headache. A “neurological event” is defined herein as either the precursor of an event such as an epileptic seizure, or the epileptic seizure itself.[0003]
• Maurer and Sorenson in U.S. Pat. No. 4,019,518 describe a combined internal/external system for electrical stimulation of the body with biphasic pulses but do not describe any means of detecting neurological events. Fischell in U.S. Pat. No. 4,373,527 describes a programmable medication infusion system but does not anticipate its use in response to a detected neurological event.[0004]
• More recently, a device has been approved for human use to stimulate the vagus nerve in a continuous fashion with the objective of decreasing the rate of epileptic seizures. Clinical reports on such devices indicate only a modest degree of success in that only 50% of the patients experience a greater than 20% reduction in the rate of epileptic seizures. Another device that has been recently introduced into clinical practice utilizes continuous stimulation of the thalamus for the treatment of involuntary motion disorders such as Parkinson's syndrome.[0005]
• Neither of these two open-loop devices described above is highly effective for the treatment of a neurological disorder such as epilepsy, and neither anticipates the use of decision making in order to optimize a response to turn off the neurological event nor the recording of EEG signals.[0006]
• The automatic implantable cardiac defibrillator is an example of a decision making device having data recording capability that has been successfully used in a decision based closed-loop mode for the treatment of ventricular fibrillation. However, the requirements for detection and treatment of ventricular fibrillation are significantly simpler and certainly different from the requirements for a device to detect and treat an impending epileptic seizure. Specifically, an implantable cardiac defibrillator requires only a single signal, namely the heart's ECG, in order to detect a fibrillation event. What is more, only a single pair of electrodes is required for detection of the fibrillation event and that same pair of electrodes can be used to provide an electrical stimulus for electrical defibrillation. A heart defibrillator electrode is adapted to be placed on or in close proximity to the heart and is not suitable for use as a brain electrode.[0007]
• Coker and Fischell in U.S. Pat. No. 4,581,758 describe sophisticated signal processing techniques using the sum of squared signals from two microphones to identify the direction with respect to a person from whom human speech originates. Although the Coker and Fischell patent teaches several signal processing techniques which may be applied with others to detect neurological events, the Coker and Fischell method is aimed at identifying the location of the speech source, while one of the goals of the present invention is to utilize the known location of the source of EEG signals to help identify an abnormal EEG which signifies an impending neurological event.[0008]
• The NeuroCybernetic Prosthesis System recently made available for the treatment of epileptic seizures, utilizes continuous open-loop stimulation of the vegas nerve. This device does not sense the onset of an epileptic seizure, and it utilizes wires that are placed in the neck. Because of the frequent motions of such wires, they will have a tendency to fracture. No existing system utilizes electrodes, electrical wires and a control module that are entirely contained within the patient's scalp and essentially all contained within the patient's cranium. Such systems would not have any repeated bending of connecting wires thereby improving long term reliability. Furthermore, the NeuroCybernetic Prosthesis System does not use a rechargeable battery, nor does it utilize a separate external device controlled by the patient to activate the implanted system at the start of a neurological event in order to decrease the severity or time duration of the neurological event.[0009]
SUMMARY OF THE INVENTION
• The present invention is a multiple electrode, closed-loop system for the treatment of certain neurological disorders such as epilepsy, migraine headaches and Parkinson's disease. A purpose of the present invention is to overcome the shortcomings of all prior art devices for the treatment of such disorders. Specifically, the present invention combines a multi-electrode array with sophisticated signal processing techniques to achieve reliable detection of the onset of a neurological event (such as an epileptic seizure or migraine headache) typically originating from a focus of limited spatial extent within the brain. It is well known that in certain patients, epileptic seizures consistently originate from a single location within the brain. However, the system described herein is also adaptable for the treatment of a neurological event that involves a major portion or possibly all of the brain tissue.[0010]
• The present invention also provides means for generating an ensemble of coordinated electrical stimuli designed to terminate the neurological event immediately upon (or even prior to) its onset. Thus, the present invention is a responsive detection and stimulation system for the early recognition and prompt treatment of a neurological event.[0011]
• The present invention envisions a multiplicity of brain electrodes placed either within the brain, on the surface of the brain itself, or on the dura mater that surrounds the brain. Some one, several, or all of these brain electrodes can be used for detection of an abnormal neurological event such as an epileptic seizure. A responsive stimulation signal can also be applied to any one, several, or all elements of such an electrode array. The responsive stimulation signals sent to each electrode may be identical or they may be programmed to differ in amplitude, frequency, waveform, phase and time duration. It is also envisioned that sensing electrodes may be entirely separate from the electrodes used for responsive stimulation.[0012]
• The present invention envisions that a neurological event can be reliably detected in the presence of a normal EEG signal and in the presence of external noise by the use of modern and sophisticated signal processing techniques. Specifically, the electrical signal from an epileptic focus within a specific and limited spatial region within the brain can be reliably detected by combining the signals received at different electrodes that are placed at different distances from the epileptic focus. To improve signal-to-noise ratio, the signal received at a specified location which is at a specific distance from the epileptic focus could have a specific time delay to account for the propagation time it takes for the signal to reach that electrode. For example, if a first electrode is located directly over the site of the epileptic focus and a second electrode is located at a distance of several centimeters from the focus, then to combine these two signals together to optimize detection of a neurological event, the signal at the first (closest) electrode must have an added time delay to account for the time required for the signal to arrive at the position of the second electrode. Thus cross-correlation of EEG signals in the time domain is envisioned to be within the scope of the present invention.[0013]
• It is also envisioned that appropriate selection (i.e., location) of electrode sites can be used to enhance the reliability for detection and termination of a neurological event. Thus, the present invention envisions enhancement of detection by the use of the spatial domain as it applies to the positioning of detection and treatment electrodes.[0014]
• Finally, the present invention also envisions signal-to-noise enhancement for optimizing the detection of neurological events by searching for signals in a particular frequency domain. For example, a low-pass filter that excludes signals above 5 Hz could be used to enhance the reliability for detection of a neurological event for certain patients. In addition, detection may be enhanced by first conditioning the EEG signals using programmable, multiple step, signal processing. The processing steps that are envisioned for this signal conditioning include signal summing, squaring, subtracting, amplifying, and filtering.[0015]
• It is also envisioned that any combination of techniques for signal detection in the time, spatial or frequency domain could be used for providing a highly reliable system for the detection of a neurological event.[0016]
• The present invention envisions four different modalities for stopping the progression of a neurological event such as an epileptic seizure once it has been detected. A preferred method is to provide a responsive stimulation electrical signal, a second method is to release medication in response to the detection of an event, a third method is to provide an electrical short circuit in the vicinity of the epileptic focus to prevent the occurrence of a full epileptic seizure and a fourth method is the application of a sensory input through normal sensory pathways. Such sensory input could be acoustic (sound input), visual (light input), or other sensory input such as mechanical vibration or electrical stimulation of the skin. Of course it is envisioned that any two or more of these modalities can be used in combination in order to preclude, prevent or decrease the severity of a neurological event such as an epileptic seizure, migraine headache, Parkinson's disease tremor, etc.[0017]
• A valuable attribute of the present invention is the ability to record the EEG signal from any one or all of the detection electrodes. Typically the EEG signal would be continuously recorded in a first-in first-out (FIFO) digital data recording system where the current data overwrites the oldest data as memory storage capacity is exceeded. In the event that a neurological event was detected, the device would save the preceding several minutes of data while continuing to record subsequent EEG data after the application of a response such as responsive stimulation, short circuiting of some electrode(s) or the delivery of a bolus of medication. It is conceived that the device would hold in memory the recording made for several minutes both before and after the neurological event. These data would then be read out by the patient's physician on a regular basis; e.g., every three months or more frequently if the device did not promptly terminate some neurological event. It is also anticipated that the patient could use a patient's initiating device to trigger the retention of several minutes of data recording of the EEG signal from a pre-selected group of electrodes.[0018]
• It is also conceived that certain other data be recorded that can be helpful to the physician for treating the patient. These additional data would include: (1) the number of neurological events detected since the last memory readout and; (2) the number of responses triggered by the neurological events that were delivered to the patient. Furthermore, the system can be programmed so that when a neurological event is detected, the electrical signal from any one or more of the multiple steps in the signal conditioning can be stored in a digital memory. Additionally, telemetry would be provided to the physician that would indicate the serial number of the device that is implanted in the patient and the date and time that each neurological event or patient initiated recording occurred.[0019]
• Another valuable attribute of the present invention is the capability to program the functions and parameters of the system to enhance the detection of a neurological event and to optimize the system responses for stopping a neurological event such as an epileptic seizure. Examples of programmable functions and parameters are: (1) the time delay introduced for a signal being received from a specific electrode; (2) the use or non-use of a specific electrode; (3) the frequency response characteristic of the channel assigned to process the signal received from a specific electrode; (4) whether or not a particular electrode is electrically shorted to another electrode or to the metal case of the device after a neurological event has been detected; (5) the amplitude, frequency, duration, phase and wave-form of the response signal delivered to a specific electrode; (6) the allocation of memory for storing EEG signals as received from one or more electrodes; (7) determination as to whether or not the data from a particular electrode will be stored in memory; (8) the amplitude, frequency and time duration of an acoustic, visual, or other sensory input applied to the patient in response to the detection of a neurological event, and (9) the specification of statistical data (histograms) to be recorded; for example, the number of epileptic seizures and/or the number of responsive stimulations delivered since the last memory readout by an attending physician. These are some but not all of the programmable functions and parameters that the system might utilize.[0020]
• It should be understood that a telemetry signal would be transmitted from the implanted device. External receiving equipment typically located in the physician's office, would process that signal and provide a paper print-out and a CRT display to indicate the state to which all the parameters of the implanted device have been programmed. For example, the display would indicate which electrodes are active, what algorithm is being used for detection, what specific bandwidth is being used with a specific electrode, etc.[0021]
• It should be understood that, unlike implantable automatic heart defibrillators which generate a responsive signal only after ventricular fibrillation has occurred, it is a goal of the present invention to prevent full development of an epileptic seizure or migraine headache before the actual occurrence of such an unwanted neurological event. In this regard, the present invention is entirely different from any implantable medical device (such as an automatic heart defibrillator) that always allows the unwanted event to occur.[0022]
• A specific capability of this system is to provide electrical stimulation to a specific portion of the brain as the means of stopping a neurological event. It is believed that the earliest possible detection of a seizure and treatment of aberrant electrical activity from an epileptic focus has the highest probability of aborting the occurrence of a full seizure. It is envisioned that either through specific placement of treatment electrodes or by adjusting the phase of signals applied to an array of electrodes, stimulation can be directed to the location(s) within the brain that offer the highest probability of stopping the seizure.[0023]
• It is believed that there is minimal or no effect if a responsive stimulation is produced from an erroneously identified event, i.e., a false positive. On the other hand, failure to identify a real event is highly undesirable and could cause the patient to undergo a severe seizure. Therefore, the design concept of the current invention is to predispose the decision making algorithm to never miss a real event while allowing a false positive rate to be detected at up to 5 times the rate of actual events.[0024]
• Telemetry data transmitted from the implanted device can be sent to a physician's workstation in the physician's office either with the patient in the physician's office or remotely from the patient's home by means of a modem. The physician's workstation can also be used to specify all of the programmable parameters of the implanted system.[0025]
• A novel aspect of a preferred embodiment of this invention is that the entire implantable portion of this system for treating neurological disorders lies under the patient's scalp. Such placement will either have the device located between the scalp and the cranium or the within a hole in the cranium. Because of size constraints, the intracranial location is the preferred embodiment.[0026]
• The implantable portion of the system includes; (1) electrodes that lie in close proximity to or actually within the brain; (2) a control module that contains a battery and all the electronics for sensing, recording and controlling brain activity, (3) electrically conducting wires that connect the control module to the electrodes, (4) a buzzer providing an acoustic signal or electrical “tickle” indicating that a neurological event has been detected, and (5) an input-output wire coil (or antenna) used for communication of the implanted system with any and all external equipment. The battery that provides power for the system and an electronics module are both contained within a metal shell that lies under the patient's scalp. The metal shell which contains the electronics module and the battery collectively form the control module.[0027]
• All electrodes connect by means of electrically conducting wires to electrical terminals that are formed into the metal shell. The electronics module is electrically joined to the brain electrodes by means of the shell's electrical terminals which are electrically joined to the wires that connect to the brain electrodes.[0028]
• An important aspect of the preferred embodiment of this device is the fact that the shell containing the electronics module and the battery, i.e. the control module, is to be placed in the cranium of the skull at a place where a significant volume of bone is removed. By placing the entire system within the cranium, (as opposed to having some wires extending into or through the neck to a control module in the chest) the probability of wire breakage due to repeated wire bending is drastically reduced. However, the present invention also envisions the placement in the chest or abdomen of a control module if a large battery or a large volume electronics module dictates such a large size for the control module that it cannot be conveniently placed within the cranium. Such a thoracic or abdominal placement of a control module would require wires to be run through the neck.[0029]
• The present invention also envisions the utilization of an intracranial system for the treatment of certain diseases without placing wires through the neck. Specifically, an alternative embodiment of the invention envisions the use of electrodes in or on the brain with an intracranial control module used in conjunction with a remote sensor/actuator device. For example, blood pressure could be sensed with a threshold of, let us say 150 mm Hg, and if that pressure was exceeded, a signal transmitted by electrical conduction through the body from the remote sensor/actuator device could be received at the control module and that would cause brain stimulation in such a way as to reduce the blood pressure. Conversely, if the brain detects pain and provides a signal detectable by the intracranial system, a signal could be sent by electrical conduction through the body to a remote sensor/actuator device which could provide electrical stimulation to locally stimulate a nerve to reduce the perception of that pain. Still another example is that if the precursor of an epileptic seizure is detected, a remote actuator could be used to electrically stimulate one or both vagus nerves so as to stop the epileptic seizure from occurring. Such a remote device could be located in the trunk of the patient's body.[0030]
• Another important aspect of this invention is that a comparatively simple surgical procedure can be used to place the control module just beneath the patient's scalp. A similar simple procedure can be used to replace either the battery or both the battery and the electronics module. Specifically, if the hair on the scalp is shaved off at a site directly over where the control module is implanted, an incision can then be made in the scalp through which incision a depleted battery can be removed and replaced with a new battery, or a more advanced electronics module can replace a less capable or failed electronics module. The incision can then be closed, and when the hair grows back, the entire implanted system would be cosmetically undetectable. A good cosmetic appearance is very important for the patient's psychological well being.[0031]
• The manner in which the control module, the electrodes and the interconnecting wires are placed beneath the scalp is important for the successful implantation of the entire implantable system. Specifically, the control module is optimally placed in either the left or right anterior quadrant of the cranium. Because the large sagital sinus vein runs along the anterior-posterior center line of the cranium, it is inadvisable to run epidural wires through that region, and furthermore, it would be inadvisable to place the control module directly over that major vein. Since movement of the jaw causes motions of the scalp relative to the cranium, it is advisable to run the connecting wires for electrodes that must be placed on the anterior portion of the brain in the epidural space as opposed to running them between the scalp and the cranium. Since the middle meningeal artery and its branches run within grooves interior to the posterior section of the cranium, it would be inadvisable to connect to posterior placed electrodes by utilization of connecting wires positioned in the epidural space beneath the posterior portion of the cranium. Therefore, the connecting wires for electrodes to be placed on a posterior portion of the brain's surface are best located beneath the scalp, then through burr holes in the cranium where they connect to any electrodes placed in a posterior position on the surface of the dura mater. Conversely, most of the length of the connecting wires for electrodes located in the anterior portion of the brain would be placed in the epidural space. In no case should epidural wires be passed through the anterior-posterior centerline of the brain where the large sagital sinus vein is located.[0032]
• An important operational aspect of the implanted system is the use of an input-output coil formed from many turns of fine wire that is placed between the scalp and the cranium generally along the anterior-posterior center line of the head. All communication between the external equipment and the implanted system can be accomplished by magnetic induction through the hair and scalp of the patient. Examples of these signals are the readout of telemetry from the implanted system, or the changing of some operational parameter of the implanted system by means of a command from some piece of external equipment. Furthermore, such an input-output coil can be used to recharge a rechargeable battery that can be located inside the control module. Since the input-output coil can be placed on a posterior portion of the cranium, relative motion of the scalp and cranium should not be a problem in that region.[0033]
• By placing the input-output coil in an appropriate site just beneath the scalp, the patient can be provided with a cap to be worn on the head which cap includes a flexible coil that can communicate by magnetic induction using an alternating magnetic field with the implanted input-output coil. Such a cap could be placed on the patient in the doctor's office when the doctor wishes to read out stored telemetry or program one or more new parameters into the implanted system. Furthermore, the cap could be used by the patient at home for remote connection to the physicians workstation over telephone lines using a pair of modems, or the cap could be used to recharge a rechargeable battery located in the control module of the implanted system.[0034]
• Another important aspect of the system is a buzzer that can be implanted just behind the ear on the outer or inner surface of the cranium or actually within a burr hole within the cranium. If a neurological event is detected, the buzzer can provide an acoustic output that is detectable by the patient's ear or the buzzer can provide an electrical “tickle” signal. The buzzer can be used to indicate to the patient that a neurological event such as an epileptic seizure is about to occur so that an appropriate action can be taken. Among the appropriate actions that could be taken by the patient is the application of an acoustic, visual or sensory input that could by themselves be a means for stopping a neurological event such as an epileptic seizure. The acoustic input could be by means of a sound producing, hearing aid shaped device that can emit an appropriate tone as to pitch and volume directly into the ear. The visual device could be from a light emitting diode in eyeglasses or a small flashlight type of device that emits a particular type of light at some appropriate flashing rate. A sensory input could be provided by, for example, an externally mounted electrical stimulator placed on the wrist to stimulate the median nerve or by a mechanical vibrator applied to the patient's skin.[0035]
• When any such acoustic, visual or other sensory input is actuated, either automatically or manually in response to the detection of a neurological event, literally billions of neurons are recruited within the brain. The activation of these neurons can be an effective means for stopping an epileptic seizure.[0036]
• An alternative embodiment of the present invention envisions the use of a control module located external to the patient's body connected to electrodes either external or internal to the patient's scalp. Such an externally located control module might be positioned behind the patient's ear like a hearing aid.[0037]
• Thus it is an object of this invention to provide appropriate stimulation of the human brain in response to a detected neurologic event in order to cause the cessation of that neurologic event.[0038]
• Another object of this invention is to provide increased reliability for neurological event detection by the use of cross-correlated signals from multiple electrodes with appropriate time delay(s) to increase the sensitivity and reliability for detection from a specific area of the brain.[0039]
• Still another object of this invention is to exploit a spectral characteristic of the signals from multiple electrodes to optimize the detection of a neurological event.[0040]
• Still another object of this invention is to predispose the decision-making algorithm to allow false positives to cause a responsive stimulation but to disallow missing an actual event.[0041]
• Still another object of this invention is to have the response to a neurological event be an electrical stimulation that is focused on a specific area of the brain by variably delaying the stimulation signal sent from each of several stimulation electrodes placed at different locations placed in close proximity to the brain or within the brain.[0042]
• Still another object of this invention is to have the specific area of the brain onto which the response is focused be the area from which the event signal was detected.[0043]
• Still another object of this invention is to record (and ultimately recover for analysis) the EEG signal(s) from one or more electrodes before, during and after a neurological event.[0044]
• Still another object of this invention is to provide programmability for all-important operating parameters of the device.[0045]
• Still another object of this invention is to provide recording of the certain functions of the device such as how many neurological events were detected and how many times the device responded to such detections.[0046]
• Still another object of this invention is to use medication delivery as the response to a neurological event, either alone or in conjunction with electrical stimulation.[0047]
• Still another object of this invention is to utilize implanted electronic circuitry which is adaptable to changing EEG input signals so as to provide self-adaptation for the detection and/or treatment of a neurological event.[0048]
• Still another object of this invention is to have a system of electrodes connected by wires to a control module, the entire system being placed under the scalp and being essentially contained within the cranium.[0049]
• Still another object of this system is to have essentially no flexure of interconnecting wires so as to enhance system reliability.[0050]
• Still another object of this invention is to be able to replace a depleted battery within the system's control module by a comparatively simple and quick surgical procedure.[0051]
• Still another object of this invention is to be able to replace an electronics module within the system's control module by a comparatively simple and quick surgical procedure.[0052]
• Still another object of this invention is to be able to recharge the battery in the control module.[0053]
• Still another object of this invention is to provide an externally situated patient's initiating device that can be used by the patient when he or she senses that a neurological event is about to occur in order to provide a response for causing the stopping of that neurological event or in order to initiate the recording of EEG signals from a pre-selected set of electrodes.[0054]
• Still another object of this invention is to utilize a remotely located sensor/actuator device within the body to detect an abnormal physiological condition and send an electrical signal with or without wires to a control module within the cranium which then responds by an electrical signal delivered to the brain to treat the abnormal physiological condition.[0055]
• Still another object of this invention is to utilize an intracranial system for sensing some abnormal physiological condition and then sending an electrical signal with or without wires to a remote sensor/actuator device that is remotely located within the body to carry out some treatment modality.[0056]
• Still another object of this invention is to provide a buzzer which indicates to the patient that a neurological event has occurred.[0057]
• Still another object of this invention is to provide acoustic, visual or other sensory inputs to the patient either automatically or manually following the detection of a neurological event so as to stop the neurological event.[0058]
• These and other objects and advantages of this invention will become apparent to a person of ordinary skill in this art upon careful reading of the detailed description of this invention including the drawings as presented herein.[0059]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a top view of a human head showing the configuration of an implantable system for the treatment of neurological disorders as it would be situated in the human skull.[0060]
• FIG. 2 is a block diagram of the implanted and external portions of the system.[0061]
• FIG. 3 is a block diagram illustrating the event detection sub-system which utilizes digital signal processing techniques that can exploit either or both time and frequency domain information to accomplish event detection.[0062]
• FIG. 4 is a flow chart pertinent to the processing activity carried on within the programmable digital signal processor which is part of the event detection sub-system.[0063]
• FIG. 5A illustrates the amplitude of the electrical signal received at[0064]FIFO memory344A as a function of time.
• FIG. 5B illustrates the amplitude of the electrical signal received at[0065]FIFO memory344B as a function of time.
• FIG. 5C illustrates the amplitude of the electrical signal received at[0066]FIFO memory344C as a function of time.
• FIG. 5D illustrates the sum of the time delayed signal amplitudes showing also that the event detection threshold is exceeded at −20 milliseconds.[0067]
• FIG. 6 illustrates a block diagram for an alternative algorithm for detection of a neurological event which uses the amplitude differences of signals from pairs of electrodes.[0068]
• FIG. 7 is a flow chart of the event recording and processing which is carried on within the event processing microcomputer used for the second stage of an event detection sub-system.[0069]
• FIG. 8 illustrates the recording of EEG and /or EEG spectrum signals by the central processor.[0070]
• FIG. 9 shows a flow chart of the central processor function for: (1) receiving event detection information from the event detection sub-system; (2) sending delay and threshold parameters to the event processing microcomputer and digital signal processor; (3) storing event related data; (4) inducing responsive brain stimulation through the stimulation sub-system; and (5) communicating externally for physician data read out and system programming.[0071]
• FIG. 10 is a block diagram of the stimulation sub-system as used to stimulate the brain responsive to a detected event.[0072]
• FIG. 11 is a block diagram of the data communication sub-system and external data interface.[0073]
• FIG. 12 is a block diagram of a hybrid analog/digital representation of the event detection sub-system using time domain information for event detection.[0074]
• FIG. 13 is a block diagram of a hybrid analog/digital representation of the event detection sub-system using frequency domain information for event detection.[0075]
• FIG. 14 is a block diagram of an implantable system that can respond to a detected neurological event by infusing medication into the patient's body.[0076]
• FIG. 15 is a top view of a human head showing the arrangement of a multiplicity of electrodes connected by wires to a control module that is implanted within the cranium.[0077]
• FIG. 16 is a side view of a human head showing the arrangement of one surface and one deep electrode connected by wires that pass through a hole in the cranium and connect to a control module that is implanted within the cranium.[0078]
• FIG. 17 is a top view of a human head showing the arrangement of an implanted input-output flat wire coil connected by wires to a control module that is implanted within the cranium.[0079]
• FIG. 18 is a side view of a human head showing the arrangement of the implanted input-output flat wire coil as it would be used with a patient's initiating device to trigger some operation of the implanted system.[0080]
• FIG. 19 is a side view of a human head showing the arrangement of the implanted input-output coil as it would be used with a cap and with the physician's external equipment to perform some interaction with the implanted system.[0081]
• FIG. 20 is a top view of the shell of the control module.[0082]
• FIG. 21 is a cross section of the cranium showing a control module placed essentially within the cranium within a space where cranium bone has been removed. The cross section of the shell in FIG. 21 is taken along the section plane[0083]21-21 of FIG. 20.
• FIG. 22 is a side view of the human head and torso showing an alternative embodiment of the present invention using a control module implanted within the chest.[0084]
• FIG. 23 is a side view of the human head and torso showing an alternative embodiment of the present invention using a control module implanted between the scalp and the cranium, a remote sensor/actuator device located within the chest, and external devices for applying acoustic, visual, or other sensory input to the patient.[0085]
• FIG. 24 is a side view of a human head showing alternative communication means between the external equipment and an implanted control module and also showing alternative locations for electrodes mounted in close proximity to the patient's brain.[0086]
• FIG. 25 is a side view of the human head and torso showing an alternative embodiment of the present invention using a control module located external to the patient's body and a remote sensor/actuator device located within the chest, and external devices for applying acoustic, visual, or other sensory input to the patient.[0087]
DETAILED DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates the configuration of an[0088]implantable system10 for the treatment of neurological disorders as it would be situated under the scalp of ahuman head9 having acontrol module20,electrodes15A,15B,15C,15N and16 withwires17A,17B,17C,17N and18 connected through theconnector8 to thecontrol module20. It is envisioned that thecontrol module20 is permanently implanted into the top of the skull in a location where the skull is fairly thick. It is also envisioned that thecontrol module20 could be located in the trunk of the patient's body like a heart pacemaker with the connecting wires being run under the patient's skin. Theelectrodes15A,15B,15C,15N and16 would be placed under the cranium and above the dura mater (i.e., placed epidurally) or placed deep into the brain. The connectingwires17A,17B,17C,17N and18 would be run from thecontrol module20 underneath the scalp and then be connected to the electrodes placed beneath the patient's cranium. Although FIG. 1 shows only 4active electrodes15A,15B,15C,15N with connectingwires17A,17B,17C,17N, more than 4 active electrodes with connecting wires may be used with the present invention. The electrode16 (having a connecting wire18) could be considered a common or indifferent electrode.
• Throughout the detailed description of the present invention, the terminology “the[0089]electrodes15A through15N” is meant to include allelectrodes15A,15B,15C, . . . to15N inclusive where N may be any integer between 1 and 200. Similar terminology using the words “through” or “to” for other groups of objects (i.e.,wires17A through17N) will have a similar inclusive meaning.
• Throughout FIGS. 1 through 25 inclusive, lines connecting boxes on block diagrams or on software flow charts will each be labeled with an element number. Lines without arrows between boxes and/or solid circles indicate a single wire.[0090]
• Lines with arrows connecting boxes or circles are used to represent any of the following:[0091]
• 1. A physical connection, namely a wire or group of wires (data bus) over which analog or digital signals may be sent.[0092]
• 2. A data stream sent from one hardware element to another. Data streams include messages, analog or digital signals, commands, EEG information, and software downloads to change system operation and parameters.[0093]
• 3. A transfer of information between software modules. Such transfers include software subroutine calls with and without the passing of parameters, and the reading and writing of memory locations.[0094]
• In each case, the text will indicate the use of the line with an arrow.[0095]
• FIG. 2 is a block diagram of the[0096]implantable system10 and theexternal equipment11. Thewires17A through17N from theelectrodes15A through15N, and thewire18 from thecommon electrode16, are shown connected to both theevent detection sub-system30 and thestimulation sub-system40. It is also envisioned to use the case of thecontrol module20 of FIG. 1 as the common (or indifferent)electrode16. Thewires17A through17N carryEEG signals21A through21N from theelectrodes15A through15N to theevent detection sub-system30. Theelectrodes15A through15N can be energized by thestimulation sub-system40 via thewires17A through17N to electrically stimulate the patient's brain using the stimulation signals412A through412N respectively. Although theelectrodes15A through15N and16 shown here are connected to both theevent detection sub-system30 and thestimulation sub-system40, it is obvious that a separate set of electrodes and associated wires could be used with each sub-system. Furthermore, it is envisioned that any one, several or all of theelectrodes15A through15N could be electrically connected (i.e., shorted) to theelectrode16 or to each other. This would be accomplished by appropriate switching circuitry in thestimulation sub-system40.
• The[0097]event detection sub-system30 receives the EEG signals21A through21N (referenced tosystem ground19 connected to thewire18 from the common electrode16) and processes them to identify neurological events such as an epileptic seizure or its precursor. Acentral processing system50 withcentral processor51 andmemory55 acts to control and coordinate all functions of theimplantable system10. Theinterconnection52 is used to transmit programming parameters and instructions to theevent detection sub-system30 from thecentral processing system50. Theinterconnection53 is used to transmit signals to thecentral processing system50 identifying the detection of a neurological event by theevent detection sub-system30. Theinterconnection53 is also used to transmit EEG and other related data for storage in thememory55.
• When an event is detected by the[0098]event detection sub-system30, thecentral processor51 can command thestimulation sub-system40 via theinterconnection54 to transmit electrical signals to any one or more of theelectrodes15A through15N via thewires17A through17N. It is anticipated that, if appropriateelectrical signals412A to412N inclusive are transmitted to certain locations in or near the brain, the normal progression of an epileptic seizure can be aborted. It may also be necessary for thestimulation sub-system40 to temporarily disable theevent detection sub-system30 via theinterconnection29 when stimulation is imminent so that the stimulation signals are not inadvertently interpreted as a neurological event by theevent detection system30.
• A[0099]power supply90 provides power to each component of thesystem10. Power supplies for comparable implantable devices such as heart pacemakers and heart defibrillators are well known in the art of implantable electronic devices. Such a power supply typically utilizes a primary (non-rechargeable) storage battery with an associated d-c to d-c converter to obtain whatever voltages are required for theimplantable system10. However, it should be understood that the power supply could use a rechargeable battery that is charged by means of a coil of wire in thecontrol module20 that receives energy by magnetic induction from an external coil that is placed outside the patient but in close proximity to the control module. The implanted coil of wire could also be located remotely fromcontrol module20 but joined to it by electrical wires. Such technology is well known from the rechargeable cardiac pacemaker. Furthermore, the same pair of coils of wire could be used to provide power to the implantedsystem10 when it is desired to read out stored telemetry or reprogram some portion of the implantedsystem10.
• Data stored in the[0100]memory55 can be retrieved by the patient's physician by awireless communication link72 with thedata communication sub-system60 connected to thecentral processing system50. Anexternal data interface70 can be directly connected with an RS-232 typeserial connection74 to the physician'sworkstation80. Alternately, the serial connection may be viamodems85 and750 andphone line75 from the patient's home to the physician'sworkstation80. The software in the computer section of the physician'swork station80 allows the physician to read out a history of events detected including EEG information both before, during and after the event as well as specific information relating to the detection of the event such as the time evolving energy spectrum of the patient's EEG. Theworkstation80 also allows the physician to specify or alter the programmable parameters of theimplantable system10.
• As shown in FIGS. 1 and 2, a[0101]buzzer95 connected to thecentral processor51 via thelink92 can be used to notify the patient that an event has occurred or that the implantedsystem10 is not functioning properly. The buzzer could provide a mechanical vibration (typically an acoustic signal) or an electrical stimulation “tickle” either of which could be perceived by the patient. By placing thebuzzer95 near the ear and on the top of, below, or within a burr hole in the cranium, an acoustic signal emitted by thebuzzer95 will be detectable by the patient's ear. This sound by itself can be an automatic means for stopping an epileptic seizure.
• A[0102]real time clock91 is used for timing and synchronizing various portions of the implantedsystem10 and also to enable the system to provide the exact date and time corresponding to each neurological event that is detected by theimplantable system10 and recorded in memory. Theinterconnection96 is used to send data from thecentral processor51 to thereal time clock91 in order to set the correct date and time in theclock91.
• The various interconnections between sub-systems (e.g., the[0103]interconnections52,53,54,56,57,92,93 and96) may be either analog or digital, single wire or multiple wires (a “data bus”).
• The operation of the[0104]system10 of FIG. 2 for detecting and treating a neurological event such as an epileptic seizure would be as follows:
• 1. The[0105]event detection sub-system30 continuously processes the EEG signals21A through21N carried by thewires17A through17N from theN electrodes15A through15N.
• 2. When an event is detected, the[0106]event detection sub-system30 notifies thecentral processor51 via thelink53 that an event has occurred.
• 3. The[0107]central processor51 then triggers thestimulation sub-system40 via thelink54 to electrically stimulate the patient's brain (or electrically short some electrodes or release medication) in order to stop the neurological event using any one, several or all of theelectrodes15A through15N.
• 4. The[0108]stimulation sub-system40 also sends a signal via thelink29 to theevent detection sub-system30 to disable event detection during stimulation to avoid an undesired input into theevent detection sub-system30.
• 5. The[0109]central processor system50 will store EEG signals and event related data received from theevent detection sub-system30 via thelink53 over a time from X minutes before the event to Y minutes after the event for later analysis by the patient's physician. The value of X and Y may be set from as little as 0.1 minutes to as long as 30 minutes.
• 6. The[0110]central processor51 may “buzz” to notify the patient that an event has occurred by sending a signal via thelink92 to thebuzzer95.
• FIG. 3 is a block diagram illustrating an implementation of the[0111]event detection sub-system30 using digital signal processing techniques. Theevent detection sub-system30 can use either or both, time and frequency domain information for event detection. Theevent detection sub-system30 receives thesignals21A through21N from thewires17A through17N and processes them to identify the early stages of a neurological event such as an epileptic seizure. Thesignals21A through21N are amplified by theamplifiers32A through32N respectively, to produce the amplified EEG signals22A through22N. Theamplifiers32A through32N can also provide low pass and/or high pass filtering to remove unwanted noise. Eachamplifier32A through32N can be disabled by a signal placed oninterconnection29 from thestimulation sub-system40 during brain stimulation so as to prevent overloading the amplifiers or creating an undesired input signal into theevent detection sub-system30.
• The amplified EEG signals[0112]22A through22N are then digitized by the analog-to-digital converters33A through33N producing the digitized EEG signals23A through23N which are processed by the programmabledigital signal processor34 with associatedmemory35 to enhance the signal-to-noise ratio for the detection of neurological events. Processed signals24 are then passed to theevent processing microcomputer36 with associatedmemory37 for analysis with the goal of achieving event detection. When theevent processing microcomputer36 identifies an event, it produces a detection signal which it sends along with stored EEG and EEG energy spectral data streams to thecentral processor51 through theinterconnection53. Thecentral processor51 can pass specific program parameters and revised programming instructions to theevent processing microcomputer36 via theinterconnection52. Theevent processing microcomputer36 can also pass any appropriate program parameters and revised programming instructions received from thecentral processor51 on to the programmabledigital signal processor34 via theinterconnection25. This scheme provides patient-specific optimization of event detection algorithm(s). For example the program might look at signal amplitude differences between certain electrodes, or alternately, event detection might be based on analysis of a signal created by adding the signals (possibly with varying time delays) derived from a specific subset of the electrodes. It is also possible that the programmabledigital signal processor34 might be programmed to perform both digital signal processing and event processing thus not requiring a separateevent processing microcomputer36. It is also envisioned that theevent processing microcomputer36 and thecentral processor51 may be the same microcomputer having separate subroutines in software for each function.
• The[0113]amplifiers32A through32N, the analog-to-digital converters33A through33N and the programmabledigital signal processor34 each separately and collectively constitute a signal conditioning means for processing the EEG signals21A through21N. Theevent processing microcomputer36 provides event detection means for the detection of a neurological event.
• Integrated circuit amplifiers, analog-to digital converters, digital signal processors (DSPs), digital memory and microcomputers and the techniques to interconnect and program them are well known in the art. Custom VLSI or hybrid circuits could be developed that would combine certain functions.[0114]
• FIG. 4 is a flow chart pertinent to the[0115]processing activity340 carried on within the programmable,digital signal processor34 of theevent detection sub-system30. The digitized EEG signals23A through23N are first processed by the step of removing any d-c bias by thesubroutines341A through341N producingdigital signals351A through351N which are then processed by the automatic gain control (AGC)subroutines342A through342N to produce the AGC EEG signals352A through352N. These AGC EEG signals352A through352N would then be free of any d-c bias, and be of identical maximum amplitude during that time when the brain is not experiencing a neurological event. The purpose of AGC is to remove the variation in EEG signal amplitude which can change slowly over a period of a few hours. Thus theAGC subroutines342A through342N might adjust the amplitude ofincoming signals351A through351N based on the average energy detected over a period of several minutes. However, a rapidly changing signal such as that from a neurological event would not have their amplitudes modified by theAGC subroutines342A through342N.
• Using the step of AGC at this stage of the processing will allow the use of a constant threshold for event identification at a later stage. The AGC time constant is among the programmable parameters that can be programmed in the[0116]DSP program instructions348 that are passed via theinterconnection25 from theevent processing microcomputer36. AGC algorithms which adjust the output gain based on time averaged energy are well known in the art and can be implemented by an experienced DSP programmer. It is also envisioned that theamplifiers32A through32N of FIG. 3 might be analog AGC amplifiers so that a DSP AGC algorithm would be unnecessary. AGC is an example of a self-adaptive algorithm used by theevent detection sub-system30.
• The processed EEG signals[0117]352A through352N are continuously passed via theinterconnections24 to theevent processing microcomputer36 so that they may be stored for later physician analysis if a neurological event occurs. The processed EEG signals352A through352N are also processed further by additional signal conditioning steps to enhance event identification. These steps involve first squaring thesignals352A through352N using the squaringsubroutines343A through343N to produce thesquared EEG signals353A through353N. Thesquared EEG signals353A through353N are fed into the First-In-First-Out (FIFO) buffers344A through344N where between 1 and 100 milliseconds of data can be stored. Implementing FIFO data storage in DSP software is well known and can be implemented by an experienced DSP programmer.
• Epileptic seizures and many other neurological events can originate in a comparatively small section of the brain called an epileptic focus. A preferred embodiment of the digital[0118]signal processing algorithm340 for event detection is based on the principle that the signals arriving at theelectrodes15A through15N (shown in FIG. 2) from an epileptic focus will always do so with essentially the same time delay for each electrode. Or stated another way, the propagation time required for a signal to travel from the epileptic focus to an electrode will be consistently as follows: t₁milliseconds for aelectrode15A, t₂milliseconds forelectrode15B, t₃milliseconds forelectrode15C, etc., where t₁, t₂, t₃. . . do not significantly change in value from time-to-time. TheFIFOs344A through344N are nothing more than a digital equivalent of a delay line where the sum withdelay algorithm345 can elect to sample thesquared EEG signals353A through353N with each delayed appropriately to create the time synchronized EEG signals354A through354N which are summed by the sum withdelay algorithm345. The sum withdelay algorithm345 will produce the sum of time synchronized squared signals355. EEG signals originating from parts of the brain away from the focus will not be synchronized by thealgorithm345 whose time delays are set to synchronize EEG signals originating at the focus. Thus the amplitude of the sum of time synchronized squaredsignals355 will be much larger for EEG signals originating at the focus.
• The delays for each of the FIFO buffers are programmed through the[0119]DSP program instructions348. The settings for FIFO time delays would be derived from analysis of recorded EEG signals during events from a patient having the same electrode configuration to be used for event detection.Interconnection25 is the interconnection over which theprogramming instructions348 are provided by theevent processing microcomputer36 to set the time delay parameters for the FIFO buffers.
• The[0120]signal355 can be sent to theevent processing microcomputer36 for time domain event detection. Thesignal355 can also be transformed into the frequency domain by thetransform algorithm346, which will produce a frequency spectrum that can change with time having frequency band signals356-1,356-2,356-3,356-4 through356-M which are the time evolving signals corresponding to a total of M frequency bands (band1 through band M). The frequency band signals356-1 through356-M are digital data streams, each representing the energy of thesignal355 in the corresponding frequency band (band1 through band M). An example of such frequency bands is as follows: (a) band1: 1 to 2 Hz; (b) band2: 2 to 4 Hz; (c) band3: 4 to 8 Hz; etc. The specific division of the bands is programmable through theDSP programming instructions348 and may be derived for each patient from analysis of recorded EEG information. The frequency band signals356-1 through356-M are sent to theevent processing microcomputer36 for the purpose of event detection.
• FIGS. 3 and 4 illustrate one embodiment of a multiple step signal conditioning means for the EEG signals[0121]21A through21N. The specific steps used in this embodiment are amplification, analog-to-digital conversion, adjustment of d-c offset, AGC, squaring, time delaying, summing and frequency transformation. The ability to program the programmabledigital signal processor34 to implement any combination of these or other steps in any order to enhance event detection for each patient is an important aspect of theevent detection sub-system30.
• FIGS. 5A, 5B and[0122]5C show the signal traces for a 3 electrode implementation of the present invention with thesquared EEG signals353A,353B and353C stored in theFIFOs344A,344B and344C respectively. In this example, theFIFOs344A,344B and344C store 100 milliseconds of data consisting of 20 samples each, with each sample being the average value for a period of 5 milliseconds of thesquared EEG signals353A,353B and353C. The last data placed in theFIFOs344A,344B, and344C correspond to time equals zero, and are the most recent samples of thesquared EEG signals353A,353B and353C.
• During pre-implant data recording and analysis of a patient's EEG data, the relative delays between EEG signals from an epileptic focus arriving at[0123]electrodes15A,15B and15C would be calculated. In this example, theelectrode15A from which the data inFIFO344A originates, is the last to receive the EEG signal from such an event. Thetime delay parameter358A for theelectrode15A is therefore set to 0. In this example,electrode15B which is the source of data forFIFO344B, is known to receive anevent signal 15 ms beforeelectrode15A thus thetime delay parameter358B forelectrode15B is set to 15 ms. Similarly,electrode15C from which the data inFIFO344C receives anevent signal 35 ms beforeelectrode15A; thus thesignal delay parameter358C forelectrode15C is set to 35 ms.
• Using the[0124]time delay parameters358A,358B and358C, thespecific samples354A,354B and354C (marked with theblack arrows6A,6B and6C) are fed into the sum withdelay algorithm345. The sum withdelay algorithm345 adds these specific FIFO samples together to produce thesignal355 as shown in FIGS. 4 and 5D. FIG. 5D shows the current sample of thesignal355 and the last 100 milliseconds of thesignal355 created by the sum withdelay algorithm345.
• A simple means to detect, a neurological event using the sum with[0125]delay algorithm345 with resultingsignal355 is to compare thesignal355 with a fixedevent detection threshold369 as shown in FIG. 5D. Thethreshold369 is exceeded attimes 0, −10 ms and −20 ms. This methodology can be an effective means for event detection when used in conjunction with the automaticgain control algorithms342A,342B and342C as shown in FIG. 4. The automatic gain control has the effect which is seen in FIGS. 5A through 5C of keeping the samples of the squared EEG signals below the AGC limits362A,362B and362C which limits are programmed into the automaticgain control algorithms342A,342B and342C shown in FIG. 4. The AGC subroutines342A,342B and342C might adjust the amplitude of the EEG signals352A through352N based on the average energy detected over a period of several minutes so that a rapidly changing signal such as that from a neurological event will not be affected.
• It is also envisioned that the[0126]delay parameters358A,358B and358C may be self-adaptive so that when an event is detected, post-analysis by thedigital signal processor34 using the data stored in theFIFOs344A,344B and344C can determine if adjusting thedelays358B and358C plus or minus in time would increase or decrease the sum of the time synchronized squared EEG signals355. If thesignal355 increases by a shift of thetime delay358B or358C, then thedelay parameters358B and358C could be automatically changed to increase the sensitivity for future event detection. This example of the capability to modify it's own operating parameters is an example of self-adaptation of the programmabledigital signal processor34. It is also envisioned that other programmable components of thesystem10 of FIG. 2 other than theevent detection sub-system30 may be self-adaptive to be capable of optimizing system operability without external commands.
• Although FIGS.[0127]5A-5D show the signals relating to an implementation of the present invention using 3 signal electrodes, the algorithms described can be applied to any set of 2 or more signal electrodes.
• It is also envisioned that instead of delaying the signals from each electrode to provide time synchronization, the electrodes might be placed at positions where the time delays from an epileptic focus to each electrode could be the same. Furthermore, it is envisioned that instead of squaring the value of the EEG signal amplitude, which is done to eliminate a zero average over a certain period of time, the same objective could be accomplished by rectification of the EEG signal.[0128]
• FIG. 6 shows an embodiment of the present invention in which the digital[0129]signal processor processing440 based onDSP program instructions448 takes the digitized EEG signals23A,23B,23C and23D from fourbrain electrodes15A,15B,15C and15D and creates the difference signal424 fromsignals23A and23B using thesubtraction algorithm434, and the difference signal425 fromsignals23C and23D using thesubtraction algorithm435. The difference signals424 and425 can then be multiplied byweighting factor algorithms436 and437 to adjust for difference in signal level for events arriving at each pair of electrodes. The resulting weighted differential EEG signals426 and427 are summed by thealgorithm438 to create the summeddifferential EEG signal428. The summed differential EEG signal428 can then be transformed into a set of frequency band signals456-1 through456-M by thealgorithm446 as previously described with respect to thedigital signal processing340 shown in FIG. 4.
• The embodiment of FIG. 6 will work best when the electrode pairs[0130]15A-15B and15C-15D are located in positions that will cause theEEG signal differences424 and425 to be synchronized in time for EEG signals originating at the focus of a neurological event. It is also envisioned that a programmable delay adjustment, as described for FIG. 4, could be implemented here if the time delays forEEG signal differences424 and425 from a neurological event are not the same.
• The summed[0131]differential EEG signal428, the difference EEG signals424 and425, and the frequency band signals456-1 through456-M can be sent viainterconnection24 to theevent processing microcomputer36 for storage.
• It is also envisioned that instead of digitizing the signal from each[0132]signal electrode15A through15N, with respect to acommon electrode16, the input stage could use any one or more pairs of brain electrodes with no single common electrode.
• The[0133]processing340 of FIG. 4 and440 of FIG. 6 are examples of two different implementations of multiple step signal conditioning programs which can be run within the programmabledigital signal processor34 of FIGS. 2 and 3.
• FIG. 7 shows the software flow chart for event recording and processing[0134]360 of theevent processing microcomputer36 used for the second stage of theevent detection sub-system30 shown in FIGS. 2 and 3. Specifically, event recording andprocessing360 represents the algorithms and subroutines in software used by the event processing microcomputer36 (hardware) as the event detection means and also to record relevant EEG and spectral band data. A primary objective of event recording andprocessing360 software is to make possible the recording of AGC modified EEG signals352A through352N inclusive and the frequency band signals356-1 to356-M inclusive by thecentral processing system50.
• FIG. 8 indicates that the[0135]central processing system50 is capable of recording EEG and frequency band data for “X” minutes before a neurological event is detected and “Y” minutes after the neurological event is detected. The event recording and processing360 of FIG. 7 is used to facilitate this data recording capability. Specifically, the EEG signals352A through352N (also see FIG. 4) are stored indata FIFO memories363A through363N. If an event is detected, theFIFOs363A through363N can be read by thecentral processor51 via thelink53 to retrieve the stored EEG data streams373A through373N for a time “X” minutes before the event. Thecentral processor51 can also read the data FIFOs363A through363N in real time after detection of a neurological event for a period of “Y” minutes. Alternatively the data FIFOs363A through363N could be used to store and then read out “Y” minutes of data stored after the event is detected. In either case, the goal of retrieving “X” minutes of pre-event detection data and “Y” minutes of post-event detection data (as indicated in FIG. 8) can be achieved. It should be remembered that if there are N electrodes then there will be as many as N channels of AGC modified EEG data that can be recorded. However, thecentral processing system50 may be programmed to record EEG data from a sub-set of theelectrodes15A through15N (see FIG. 2). All data stored by thecentral processing system50 can be retrieved by the patient's doctor for analysis with the goal of improving the response of thesystem10 so as to more reliably stop a neurological event.
• FIG. 7 also shows two different schemes for detecting an event. If the amplitude of the sum of the time synchronized squared[0136]EEG signals355 exceeds theevent detection threshold369 as shown in FIG. 5D (usingthreshold detector algorithm368 of FIG. 7), thealgorithm368 sends a positive event detectedmessage358 to the event density counter/detector algorithm371. The event density counter/detector algorithm371 determines if there have been enough events in the most recent time period “T” to notify thecentral processor51 with the event identifiedmessage372 indicating that an event has really occurred. A typical time period “T” would be approximately 2 seconds but could be in the range from ½ to 100 seconds. The event density counter/detector algorithm371 will reduce the number of false positive event identifications by eliminating short uncorrelated EEG bursts. If the number of events in the time period “T” is set equal to 1, then the system will be most sensitive and any time sample which exceeds thethreshold369 in thethreshold detector algorithm368, will be passed on as an event identifiedmessage372. A typical setting for the number of events for a two second time period “T” would be four.
• The system for detecting a neurological event based on the[0137]threshold detector368 would involve processing data for the entire frequency spectrum of the sum of the time synchronized and squared EEG signals355. As shown in FIG. 4 thesignal355 can be transformed into a set of frequency band signals356-1 through356-M inclusive each of which signals is of limited bandwidth as compared with thebroadband signal355. Each of the frequency band signals356-1 through356-M of FIG. 7 can be analyzed by a threshold detector algorithm367-1 through367-M respectively in a manner exactly analogous to thethreshold detector algorithm368 used to detect events from thebroadband signal355.
• In a manner analogous to the[0138]threshold detector algorithm368, each of the set of threshold detector algorithms367-1 through367-M can send a positive event detected signal357-1 through357-M to a corresponding frequency band event density counter/detector369-1 through369-M when the amplitude of the frequency band signal356-1 through356-M exceeds a preset threshold level. The frequency band event density counter/detectors369-1 through369-M will, analogous to the event density counter/detector371, determine if there are a sufficient number of events per time period “T” in any of thebands1 through M to send an event identified message359-1 through359-M to thecentral processor51 indicating that a neurological event has occurred.
• Analogous to the storage of the AGC modified EEG signals[0139]352A through352N by the data FIFOs363A through363N, each of the M frequency band signals356-1 through356-M is stored in FIFO memories366-1 through366-M, so that if an event is detected, the FIFOs can be read by thecentral processing system50 via thelink53 to retrieve the frequency band data streams376-1 through376-M for a time “X” before event detection until some time “Y” after event detection. As previously described, FIG. 8 illustrates this concept for data storage.
• Constructing computer code to store and retrieve sampled digital signals from FIFO memory is well known in the art of software design. Comparing an input signal amplitude against a preset threshold, determining the number of counts per unit time and comparing the counts per unit time against a preset number of counts per unit time are also well known in the art of software design.[0140]
• It should be understood that the software which is the digital signal processor processing[0141]340 (see FIG. 4) is run by the programmabledigital signal processor34 according to theDSP program instructions348. In a similar manner, the software for event recording and processing360 (see FIG. 7) is run by theevent processing microcomputer36 of FIG. 4 according to the program instructions for DSP andevent processing375. Additionally the programming instructions for DSP andevent processing375 serves as a pass through for theDSP program instructions348 of FIG. 4. The program instructions for DSP andevent processing375 are received by the event processing microcomputer36 (using the software for event recording and processing360) from thecentral processor51 via theinterconnection52. The DSP program instructions348 (see FIG. 4) are received overinterconnection25 by thedigital signal processor34 from the program instructions for DSP processing andevent processing375 of FIG. 7.
• The thresholds to be used for detection by the[0142]threshold detector algorithms368 and367-1 through367-M and the required event densities for event identification by the event density counter/detector algorithms371 and369-1 through369-M, will typically be programmed to minimize the chance of missing a “real” neurological event even though this could result in the occasional false positive identification of an event. This bias toward allowing false positives might typically be set to produce from ½ to 5 times as many false positives as “real” events.
• It is also envisioned that the software for event recording and[0143]processing360 might not require a separate microcomputer but could operate either as a set of subroutines in thecentral processor51 or a set of subroutines in the programmabledigital signal processor34.
• It is also envisioned that the event recording and[0144]processing software360 could be programmed to provide an event detection means based on detecting specific aspects of the waveform of either time or frequency domain outputs of the signal conditioning by thedigital signal processor36. Such aspects of the waveform could include pulse width, first derivative or waveform shape.
• FIG. 9 shows a flow chart of the software for[0145]central processor processing510 as run by thecentral processor51 of FIG. 2. Thecentral processor51 receivesevent detection messages372 and359-1 through359-M, EEG data streams373A through373N and the frequency band data streams376-1 through376-M from theevent processing microcomputer36. Thecentral processor51 of FIG. 2 also sends and receives data to and from thedata communication sub-system60 viainterconnections56 and57. The processing510 processes these messages, signals, and data streams.
• [0146]Algorithm514 receives theevent detection messages372 and359-1 through359-M provided by theevent processing microcomputer36 via thelink53. When thealgorithm514 receives such a message indicating that a neurological event has occurred, thealgorithm514 calls thesubroutine512. The calling of thesubroutine512 by thealgorithm514 is indicated by theelement515. Thesubroutine512 reads and saves to the central processor'smemory55 via thelink518, the last X minutes of stored EEG data streams373A through373N and frequency band data streams376-1 through376-M from theevent processing microcomputer36. Thealgorithm512 will continue to read and save to the central processor'smemory55, the next “Y” minutes of EEG data streams373A through373N and frequency band data streams376-1 through376-M from theevent processing microcomputer36. As seen in FIG. 8, these data streams may include a blank period during stimulation followed by data which can be analyzed to determine the efficacy of the treatment. Thealgorithm514 also causes asignal511 to be sent to thestimulation sub-system40 via thelink54 to cause thestimulation sub-system40 to respond as programmed to stop the neurological event.
• Values for X and Y will typically be several minutes for X and as much as a half-hour for Y. The[0147]memory55 must be large enough for at least one event and could be large enough to hold 10 or more events. The values X and Y like other parameters are programmable and adaptable to the needs of each particular patient.
• The I/[0148]O subroutine517 receives physician commands from thedata communication sub-system60 via thelink56 and, in turn, reads and sends back via thelink57 thedata stream519 containing the event related data previously stored in thememory55 by thealgorithm512. These data are transmitted to theexternal equipment11 by thedata communication sub-system60 via thewireless link72 as shown in FIGS. 2 and 11.
• The I/[0149]O subroutine517 also plays a key role in the downloading of software programs andparameters59 to the programmable sub-systems of theimplantable system10 of FIG. 2. These programmable sub-systems include theevent detection sub-system30, thecentral processing system50 and thestimulation sub-system40. The programmable components of theevent detection sub-system30 are the programmabledigital signal processor34 and theevent processing microcomputer36 shown in FIG. 3. The programming instructions andparameters59 for theprogrammable sub-systems30,40 and50 are downloaded through the I/O subroutine517 by the programming andparameters downloading subroutine516 of thecentral processor processing510. Thesubroutine516 stores the instructions andparameters59 and downloads the program instructions for DSP and event processing375 (also see FIG. 7) for theevent detection sub-system30 vialink52 to theevent processing microcomputer36. Thesubroutine516 also downloads the stimulation sub-system instructions andparameters592 via thelink54 to thestimulation sub-system40. Thesubroutine516 also updates thememory55 with the programming instructions andparameters594 for thecentral processor processing510.
• Programmable microprocessors or self-contained microcomputers, such as the Intel 8048 and 8051, which contain read only memory for basic programs and random access memory for data storage and/or program storage, can be used to implement the[0150]central processor processing510 as previously described. It is also envisioned that a custom VLSI chip involving microprocessor, signaling and memory modules could be produced specifically for this application. All of the previously described algorithms to store data, send notification signals and messages and make decisions based on input data are straightforward for a software programmer to implement based on the current state of the art.
• It is also clear that current memory technology should be suitable for EEG storage. For example, the EEG storage for a 4 electrode system using 8 bits (one byte) per sample at a sampling rate of 250 samples per second (required for frequencies up to 125 Hz) will require 60,000 bytes per minute of data storage. Having 100 minutes of storage would require only 6 megabytes, which is readily achievable using current memory chip technology. Thus if both X and Y were each 1 minute, then a total of 50 neurological events could be stored in the 6 megabyte memory.[0151]
• It is also envisioned that with well known data compression techniques such as adaptive pulse code modulation, the memory requirements can be reduced significantly.[0152]
• It should be understood that instead of using random access memory to store the EEG data, non-volatile memory such as “flash memory” could be used to conserve power.[0153]
• FIG. 10 illustrates the[0154]stimulation sub-system40 including its interconnections to other sub-systems. Thestimulation sub-system40 is used to stimulate the brain, responsive to a detected event. The preferred embodiment of thestimulation sub-system40 comprises adelay processing microcomputer420 andN signal generators422A through422N attached to theelectrodes15A through15N by thewires17A through17N. Theevent detection signal511 from thecentral processor51 is received by thedelay processing microcomputer420 which first sends a signal via thelink29 to theevent detection sub-system30 to shut down event detection during stimulation. Thedelay processing microcomputer420 will then feed stimulation command signals410A through410N to thesignal generators422A through422N for a specific pre-programmed time period. The stimulation command signals410A through410N may be simultaneous or may have a relative delay with respect to each other. These delays can be downloaded by the instruction andparameter download592 from thecentral processor51 via thelink54. It may be desirable that the delays be adjusted so that the stimulation signals412A through412N from thesignal generators422A through422N reach the neurological event focus in the brain at the same time and in-phase. This could enhance performance of thestimulation sub-system40 in turning off a neurological event. Alternately, experience may indicate that certain signals being out of phase when they arrive at the neurological event focus may be particularly efficacious in aborting a neurological event.
• The stimulation command signals[0155]410A through410N can be used to control the amplitude, waveform, frequency, phase and time duration of the signal generators' output signals.
• The[0156]typical stimulation signals412A through412N generated by thesignal generators422A through422N should be biphasic (that is with equal energy positive and negative of ground) with a typical frequency of between 30 and 200 Hz, although frequencies of between 0.1 and 1000 Hz may be effective. It is also envisioned that pure d-c voltages might be used, although they are less desirable. If frequencies above 30 Hz are used, the signal generators could be capacitively coupled to thewires17A through17N. The typical width of the biphasic pulse should be between 250 and 500 microseconds, although pulse widths of 10 microseconds to 10 seconds may be effective for a particular patient. Typical voltages applied may be between 1 millivolt and 10 volts rms. The stimulation would typically be turned on for several seconds although times as short as a 1 millisecond or as long as 30 minutes may be used.
• Biphasic voltage generation circuits are well known in the art of circuit design and need not be diagrammed here. Similarly, the code to have the[0157]delay processing microcomputer420 provide different command parameters to thesignal generators422A through422N is easily accomplished using well known programming techniques.
• Although the[0158]delay processing microcomputer420 is shown here as a separate unit, it may be practical to have thecentral processor51 or theevent detection microcomputer36 of FIG. 3 provide the required processing. Consolidating many of the processing functions within a single processor is practical with thesystem10 of FIG. 2 as the real time demands on any one system typically occurs when the others are not extremely busy. For example, during processing to identify an event, there is no need for data I/O, EEG storage or stimulation. When an event is detected and there is a need for EEG storage and stimulation, there is reduced need for event detection processing.
• It is also envisioned that the[0159]stimulation sub-system40 could operate with only one electrode such as a single electrode centrally located at an epileptic focus, or a deep electrode implanted in the thalmus or the hippocampus of the brain. If this were the case, thedelay processing microcomputer420 would not be needed, and only a single signal generator circuit would be required. By “located at an epileptic focus” it is meant that the electrode would be placed within 2 centimeters of the center of that focus.
• FIG. 11 shows the block diagram of the[0160]data communication sub-system60 and theexternal data interface70 including interconnections to thecentral processor51 and the physician's work-station80. When communication from the physician'sworkstation80 to thecentral processor51 is desired, theantenna730 of the external data interface is placed near theantenna630 of thedata communication sub-system60. Theworkstation80 is then connected by thecable74 to an RS-232 serialdata interface circuit740 of theexternal data interface70. The RS-232 serialdata interface circuit740 connects to theRF transmitter720 andRF receiver710 through theserial connections722 and712, respectively. Alternatively, if the patient is remotely located from the physician'sworkstation80, theworkstation80 can be connected to the RS-232 serial data interface over a dial-upconnection75 using themodems750 and85.
• Once the[0161]connection74 or75 has been established, wireless signals72 can sent to and from the RF transmitter/receiver pair610 and620 of thedata communication sub-system60 and the RF transmitter/receiver pair710 and720 of theexternal data interface70. The wireless signals72 are used to command software updates via thelink612 through the serial-to-parallel data converter614 and thelink56 to thecentral processor51. The wireless signals72 are also used to send stored data back through thelink57 through the parallel-to-serial data converter624 through thelink622 to theRF transmitter620.
• RF transceiver circuitry and antennas similar to this are used in data communication with heart pacemakers and defibrillators, and therefore, this technology is well known in the art of implantable programmable devices. RS-232 interfaces, serial to parallel and parallel to serial conversion circuits, are also well known.[0162]
• FIG. 12 is a block diagram of a hybrid analog/digital embodiment of an[0163]event detection sub-system130 that uses time domain information for event detection. In this embodiment,analog circuitry139 is used to process and detect possible neurological events, anddigital logic circuitry138 is used to check if the density of possible events is sufficient to declare a “real” event. As in FIG. 3, the incoming EEG signals21A through21N onwires17A through17N are amplified by theamplifiers131A through131N which may also provide band-pass or low-pass filtering and/or AGC of thesignals21A through21N resulting in the amplifiedsignals121A through121N which are then squared by thesquarer circuits132A through132N resulting in the squared signals122A through122N. The squared signals122A through122N are then processed by a series of analogdelay line circuits133A through133N to create the squared and time synchronized EEG signals123A through123N, which are subsequently added together by the summingcircuit135. The resulting summed time synchronizedsignal125 is then fed into athreshold detection circuit136 which will output adigital pulse126 whenever the summed time synchronizedsignal125 exceeds a pre-set threshold. Thedigital pulses126 collected over time are then processed by thedigital logic circuit138 to determine if the event is real or not. Thedelay parameters124A through124N are input to thedelay lines133A through133N from thecentral processor151 and can be pre-set for a particular patient. Setting the values for these time delays could be based on measured delays of EEG signals received from an epileptic focus during diagnostic testing of the patient using the implantedsystem10 of FIG. 2. During brain stimulation, asignal129 is sent from thestimulation sub-system40 to shut down theamplifiers131A through131N to avoid amplifier overload or mistakenly identifying a stimulation signal as a neurological event signal.
• Analog integrated circuits to multiply or sum analog signals are commercially available. Integrated circuit bucket brigade analog delay lines are also commercially available. It is also envisioned that a hybrid circuit containing multipliers, summers and delay lines could be produced to miniaturize the[0164]system130. A standard comparator circuit, also available as an integrated circuit, can be used as thethreshold detector136 to compare thesignal125 with a preset threshold. If the threshold is exceeded, then a pulse is sent via theconnection126 from thethreshold detector circuit136 to theevent counter141 of thedigital logic138.
• The[0165]digital logic138, which counts the number of event pulses per second emitted by thethreshold detector136, can be implemented using a simple programmable microcomputer similar to that described for event recording andprocessing360 shown in FIG. 7, or it can be implemented by a collection of standard digital logic and counting circuitry. Such a set of circuitry could use acounter141 to count thepossible event pulses126 generated by thethreshold detector136. An event detectedpulse128 would be emitted by thecounter141 only when it overflows. If thecounter141 is reset once a second by areset pulse147 from anOR gate146 which has been sent apulse144 from theclock142, then only if thecounter141 overflows in the one second time period betweenreset pulses147 will the event detectedpulse128 be generated. Certain available counter chips can be reset to a preset number rather than 0. In FIG. 12, theevent counter141 could be implemented with such a counter chip so that a reset signal will cause the counter to reset to apreset number148 that would be set via theconnection145 from thecentral processor151. Thus, for example, an 8 bit counter (which counts up to the number 256) could be set to overflow when the number of pulses counted by thecounter141 causes it to count from the downloadedpreset number148 to the number two hundred and fifty-six in less than one second. Of course, times of less than 1 second or more than 1 second can also be used for the time between thepulses144 from thereset clock142. The event detectedpulse128 is also used to reset both theclock142 and theevent counter141. An ORgate146 will allow theevent counter141 to be reset by either thepulse144 from theclock142 or the event detectedpulse128. The processing by thecentral processor151 would be analogous to that shown in FIG. 9.
• The specific threshold to be used for detection by the[0166]threshold detector136 and the preset148 for theevent counter141 will typically be set to minimize the chance of missing a “real” event even though this will result in occasional false positive identification of an event.
• FIG. 13 is a block diagram of a hybrid analog/digital representation of still another embodiment of the[0167]event detection sub-system230 using frequency domain information for event detection. In this embodiment,analog circuitry239 is used to process and detect possible events in each of M frequency bands.Digital logic circuitry238 is used to check if the density of possible events is sufficient to declare a “real” event. The front end (up through and including the sum135) of theanalog circuitry239 of thesub-system230 is identical to the front end of theanalog circuitry139 of FIG. 12. As in FIG. 12, the incoming EEG signals21A through21N onwires17A through17N are amplified by theamplifiers131A through131N. Theseamplifiers131A through131N (which may also provide band-pass or low-pass filtering of thesignals21A through21N) produce the amplifiedsignals121A through121N. The amplified signals121A through121N are then squared by thesquarer circuits132A through132N resulting in the squared signals122A through122N. The squared signals122A through122N are then processed by a series of analogdelay line circuits133A through133N to create the squared and time synchronized EEG signals123A through123N, which are subsequently added together by the summingcircuit135. The resulting summed time synchronizedsignal125 is fed to a set of analog band-pass filters266-1 through266-M for the M frequency bands. The resulting band signals256-1 through256-M are examined by the threshold detectors267-1 through267-M analogous to thethreshold detector136 of FIG. 12. Each of the threshold detectors (267-1 through267-M) will generate a corresponding pulse (257-1 through257-M) when a preset threshold is exceeded analogous to thepulse126 generated by thethreshold detector136 of FIG. 12. The pulses257-1 through257-M are fed into the event density counter/detectors268-1 through268-M each identical to thedigital logic circuit138 of FIG. 12. The event density counter/detectors268-1 through268-M will feed the detected frequency band event pulses258-1 through258-M to thecentral processor251.
• The[0168]central processor251 processes events from event density counter/detectors in a similar manner to thecentral processor151 of FIG. 12. The main differences are that the counter presets259-1 through259-M may be different for each of the bands as required to optimize sensitivity. During responsive brain stimulation, asignal129 is sent from thestimulation sub-system40 to shut down theamplifiers131A through131N to avoid amplifier overload or mistakenly identify a stimulation signal as an event signal. The processing by thecentral processor251 would be analogous to that shown in FIG. 9.
• FIG. 14 is a diagram of an[0169]implantable system910 which can respond to a detected neurological event by infusing medication from animplantable medication system91 into the patient's body through thehollow catheter93. Thesystem910 is identical to thesystem10 of FIG. 2 except that the programmabledrug delivery sub-system91 replaces thestimulation sub-system40 of FIG. 2 as the sub-system which provides the response to an neurological event detected by theevent detection sub-system30. In this embodiment, the signal indicating that an event has been detected and the programming instructions for the implantabledrug delivery system91 are transmitted via thelink96 from thecentral processor51. It may be desirable to place the outlet of thecatheter93 into the cerebrospinal fluid (CSF) to provide rapid infusion to all areas of the brain, or it may be desired to have the outlet of thecatheter93 positioned to deliver medication to one specific location in the brain or possibly into the bloodstream.
• The operation of the[0170]system910 of FIG. 14 for detecting and treating a neurological event such as an epileptic seizure is as follows:
• 1. The[0171]event detection sub-system30 continuously processes the EEG signals21A through21N carried by thewires17A through17N from theN electrodes15A through15N.
• 2. When an event is detected, the[0172]event detection sub-system30 notifies thecentral processor51 via thelink53 that an event has occurred.
• 3. The[0173]central processor51 signals thedrug delivery system91 via thelink96 to infuse medication through thecatheter93 into the patient's body as a means for stopping a neurological event.
• 4. The[0174]drug delivery system91 delivers pre-programmed drug infusion to the desired site.
• 5. The[0175]central processor51 will store EEG and event related data from X minutes before the event to Y minutes after the event for later analysis by the patient's physician.
• 6. The[0176]central processor51 may initiate a “buzz” to notify the patient that an event has occurred by sending a signal via thelink92 to thebuzzer95.
• Programmable implantable drug delivery systems are described in some detail in the Fischell U.S. Pat. No. 4,373,527. It is also envisioned that both electrical stimulation and drug delivery could be used together to improve the outcome in the treatment of a neurological disorder.[0177]
• It should also be understood that although the invention described herein has been described with analog or digital implementations of various aspects of the invention, the invention may combine analog and digital elements described herein in different combinations than as described.[0178]
• In addition, although the previous descriptions relate to a fully implantable system, an externally worn system with implanted electrodes could function adequately and would allow a plug-in interface to the[0179]data communication sub-system60 and simple battery replacement. It is also envisioned that the techniques described above would work with an external device with electrodes attached to the outside of the head. External devices would have great merit in determining if an implantable system would work well enough to be warranted. An external version with implanted electrodes could be used to record EEG signals from neurological events to calculate the optimal programming algorithms and parameters to be used by a permanently implanted system using the same set of electrodes.
• It is also envisioned that the EEG recording capabilities of the present invention could be used without the event detection and stimulation components to store patient EEG activity for diagnostic purposes.[0180]
• Novel arrangements for the physical placement of the various parts of a system for the treatment of neurological disorders are shown in FIGS.[0181]15 to25 inclusive. Specifically, FIG. 15 shows a top view of anintracranial system600 consisting ofbrain surface electrodes601,602,603,604,605 and606 connected bywires611,612,613,614,615 and616 respectively which provide an electrical conducting means to join theelectrodes601 through606 to acontrol module620. Thus the proximal end of each of thewires611 through616 is connected to thecontrol module620, and the distal end of each of thewires611 through616 is connected to an electrode. Inside the patient'shead9, these surface electrodes601-606 are placed between the bottom of the cranium (i.e., inside the skull) and the top of the dura mater that surrounds the brain. Thus this is an epidural placement of the surface electrodes. Although six surface electrodes are shown in FIG. 15, it is envisioned that as many as 12 or more active electrodes could be usefully implanted. It is further envisioned that the metal case of thecontrol module620 could serve as a common or indifferent electrode which also could be considered to be at ground potential. It is further envisioned that the control module might utilize a case which is non-conducting in which only part of the outer surface is conducting so as to provide one or more electrodes. Also shown in FIG. 15 is adeep electrode601D connected bywire611D to thecontrol module620. It is anticipated that as many as eight deep electrodes could be used with theintracranial system600. One or more deep electrodes might advantageously be placed in the hippocampus and/or the thalmus or possibly some other portion of deep brain tissue.
• FIG. 16 is a simplified side view of the[0182]human head9 into which theintracranial system600 has been implanted. In this simplified view, only onebrain surface electrode602 is shown and onedeep electrode601D. Thebrain surface electrode602 is connected by theinsulated wire612 to controlmodule620. Also shown in FIG. 16 is thedeep electrode601D connected by thewire611D to thecontrol module620.
• FIGS. 15 and 16 also show that the[0183]control module620 is located in an anterior portion of the patient'shead9. By an anterior portion is meant that it is located anterior to the head's lateral centerline (LCL) that roughly goes through the center of the ears. Furthermore, thecontrol module620 cannot be situated on the anterior-posterior centerline (APCL) because just under the APCL is the very large sagital sinus vein, and it would be inadvisable to place thecontrol module620 at such a location. The reason for placing thecontrol module620 in the anterior half of the patient's cranium is that the middle meningeal artery and its branches, (which arteries all lie posterior to the LCL) cause grooves to be formed in the underside of the cranium. Therefore, that location is also inappropriate for removing the considerable volume of cranium bone that should be removed for placement of thecontrol module620.
• FIGS. 15 and 16 also show that the electrodes are connected by wires to the[0184]control module620 via holes that are made by removing bone from the patients cranium. Specifically, the interconnectingwires611,612,613 and614 pass respectively through the holes H1, H2, H3 and H4. It can also be seen in FIG. 15 that thewire616 passes through the hole H1 andwires615 and611D pass through the hole H4. The reason for this method of sometimes running most of the wire length between the scalp and the cranium and at other times running most of the wire length between the bottom of the cranium and the dura mater has to do with the movement of the scalp relative to the cranium which occurs on the anterior portion of the patient's head and also is done to avoid placing the wires epidurally where the middle meningeal artery and its branches have made grooves in the interior surface of the cranium. Specifically, it will be noted that thewires612 and613 are placed under the scalp for most of their length because in this posterior portion of the patient's head the scalp exhibits very little motion relative to the cranium but the middle meningeal artery and its branches do cause interior surface grooves in the cranium in this posterior region of the head. The reverse situation is seen for the connectingwires615 and616. In this case, because there is considerable motion of the scalp relative to the cranium in the anterior portion of the patient's head, most of the length of thewires615 and616 is placed epidurally where there are no grooves in the interior surface of the cranium.
• Indicated by phantom lines in FIG. 15 is the location of an[0185]epileptic focus630 where anelectrode601 has been placed. As previously described, it may be advantageous to provide an electrical short circuit between such anelectrode601 located over theepileptic focus630 and the metal case of thecontrol module620 which acts as an indifferent, common or ground electrode. Also, responsive stimulation using only theelectrode601 may be sufficient to abort an epileptic seizure with no other electrode being actuated.
• FIG. 17 shows the location of the[0186]control module620 connected bywires631 and632 to a flat wire input-output coil635 that is placed in a posterior position on the patient's head along the APCL.
• FIG. 18 shows a cross section of the patient's cranium along the APCL showing the cross section of[0187]flat wire coil635 and also shows apatient initiating device750 having acase751 and an initiatingbutton752.
• FIG. 19 shows a cross section of the patient's cranium along the APCL again showing the cross section of the[0188]flat wire coil635 and also the cross section of acap636 which includes a flat wire input-output communication coil637. The flat wire coils635 and637 can act as emitting and receiving devices to provide two-way communication between thecontrol module620 and theexternal equipment11.
• The[0189]flat wire coil635 serves several important functions for the operation of the implantedsystem10. A first use is as the means to communicate by magnetic induction between theexternal equipment11 and the implantedsystem600. By “magnetic induction” is meant that an alternating magnetic field generated by (for example) thecoil638 generates an electrical current in thecoil635. Such an alternating magnetic field can also be modulated to provide the wireless two-way communication link72 of FIG. 2. Theexternal equipment11 via thecommunication coil637 can be used to read out telemetry stored in thecontrol module620 or reprogram thecontrol module620 with new software or operational parameters. Another use of theflat coil635 is to allow the patient's initiatingdevice750 to cause a specific action to occur within the implantedsystem10. For example, thedevice750 can be used to trigger a response from the implantedsystem600 that would be initiated by the patient when he or she feels that some neurological event was about to occur. For example, when the aura of a seizure is felt or some visual manifestation of a migraine headache, the patient would place thedevice750 over the site of the implanted control module and then press theactuate button752. Thedevice750 might have several buttons to initiate different responses from the implantedsystem600. One response that the patient may wish to have accomplished is to hold in memory the prior several minutes of recorded EEG data if the patient feels that data may be important to an understanding of his neurological condition. Furthermore, the pressing of different buttons could be used to initiate some different response from the implantedsystem600. Specifically, by pressing on thebutton752, a coil within the patient's initiatingdevice750 can communicate by magnetic induction with theflat coil635 to carry out a specific action such as: (1) hold data stored in the FIFOs to be read out at a later time, (2) provide a pre-programmed response to stop a neurological event, (3) turn off the implanted system, and (4) initiate any other action requested by the patient that has been pre-programmed by the physician. Another use for theflat coil635, as shown in FIG. 19, is to connect thecommunication coil637 via thewire638 to thecharging equipment639 as required to recharge a rechargeable battery that would be located in thecontrol module620. Theexternal equipment11 could also provide electrical power to thecontrol module620 during readout of telemetry or during reading in of new operational parameters. Powering thecontrol module620 from an external source during such times of high power drains could extend the lifetime of a primary (non-rechargeable) battery located in thecontrol module620.
• Although FIG. 17 shows the[0190]flat coil635 located remotely from thecontrol module620, such a coil could also be placed on the surface of or interior to thecontrol module620. Remote placement has the advantage that the high frequency and intense alternating magnetic field required for communication or recharging would not be placed onto the electronics portion of thecontrol module620 thus avoiding interference with the operation of thesystem600. The coupling by magnetic induction of thecoil635 with either thedevice750 or thecommunication coil637 can provide thewireless communication link72 of FIG. 2. It is envisioned that any of the two-way communication capabilities described herein could be implemented with either the electromagnetic induction structures as shown in FIGS. 17, 18 and19 or by the radio frequency (RF) components shown in FIG. 11.
• FIG. 20 is a top view of a thin-[0191]walled metal shell621 which acts as a base for thecontrol module620. FIG. 21 is a cross section of thecontrol module620 and also shows the cross section of theshell621 as indicated by the section21-21 in FIG. 20. FIGS. 20 and 21 show that theshell621 has aflange622 and four holes through which are insertedbone screws623 that attach theshell621 to the bony structure of the cranium. Also shown in FIG. 20 and21 are input wires (of which onlywire611 is indicated) that enter the insulatingstrain relief structure640. On the interior of theshell621 are male connectingpins641 which are designed to mate with a female receptacle which forms part of theelectronics module626 that is shown in FIG. 21. Theelectronics module626 contains most if not all of the electronic circuitry that is contained within thecontrol module620. Also shown in FIG. 21 is thebattery625 which has atop plate624 that extends over theflange622 of theshell621. An O-ring627 is used to provide a fluid seal to prevent body fluids from entering thecontrol module620. A silicone rubber adhesive or small metal screws could be used to join thetop plate624 to theflange622 of theshell621. Theshell621,battery625, andelectronics module626 constitute the three major parts of thecontrol module620.
• The[0192]control module620, is designed for easy implantation within a space in the cranium where the bone has been removed. The thickness of the cranium at the site of the implantation would be approximately 10 mm. Therefore, the thickness of thecontrol module620 would be approximately the same 10 mm with a diameter of approximately 40 mm. To implant thecontrol module620, the hair would be shaved over the implantation site, an incision would be made in the scalp, and the bone would be removed to make room for thecontrol module620. In a similar manner, holes such as H1-H4 inclusive would be made in the cranium for the pass-through of wires connecting to the brain electrodes.
• Although FIG. 21 shows the[0193]electronics module626 located beneath thebattery625, it also envisioned that those positions could be reversed if such positioning offered a more advantageous construction. In either case, either thebattery625 or theelectronics module626 could be readily replaced through a simple incision in the scalp over the site of the implantedcontrol module620 after the hair has been removed from the incision site.
• FIG. 22 illustrates an alternative embodiment of the invention in which the[0194]system700 for the treatment of neurological disorders utilizes acontrol module720 that is located in the patient's chest. Thesystem700 usesepidural electrodes701,702 and703 and adeep electrode701D; the electrodes being joined by connectingwires711,712,713 and711D, respectively, through awire cable710 to thecontrol module720. Theelectrode701 is shown placed at anepileptic focus730. This system can be used in exactly the same manner as previously described for thesystem10 that had acontrol module20 that was placed within the cranium.
• FIG. 23 illustrates another embodiment of the invention which utilizes a control module placed between the patient's scalp and cranium and a remotely located implantable sensor/[0195]actuator device850 located within the patient's body but not in the patient's head. Thesystem800 could operate in one of two modes. In the first mode, the sensor/actuator device850 would operate as a sensor for sensing some physiological condition such as an elevated blood pressure or an electrical signal from a nerve or muscle indicating the presence of pain. Theactive electrode854 is connected by thewire851 to the sensor/actuator device850 using the metal case of the sensor/actuator device850 as an indifferent electrode. An electrical signal in thefrequency range 1 to 500 kHz emitted from theelectrode854 could be used to communicate with thecontrol module820, thus providing a signaling means to thecontrol module820 from the remote sensor/actuator device850. Of course, such signaling means can also be provided from thecontrol module820 to the sensor/actuator device850. The electrical signal from the sensor/actuator device850 would be detected between theactive electrode801 and an indifferent electrode that could be the metal case ofcontrol module820 or it could be a separate electrode. Theactive electrode801 is connected to thecontrol module820 by the connectingwire811. It should be noted that in FIG. 23, theelectrode801 is placed epidurally at the bottom of the hole H8. This can be a comparatively simple way to place an epidural electrode.
• Having received a signal from the sensor/[0196]actuator device850 acting as a sensor, thecontrol module820 would send a signal via thewire812 toelectrode802 to act on that portion of the brain that would result in a treatment of the physiological condition that caused the sensor/actuator device850 to communicate with thecontrol module820. Thus, for example, if theelectrode854 detects a pain signal from a nerve in the back, theelectrode802 could be used to turn off a certain region of the brain so that the patient would not perceive that pain.
• A second mode of operation for the[0197]system800 would be when the intracranial portion of thesystem800 is used for sensing an adverse physiological condition, and the sensor/actuator device850 is used as an actuator to carry out some treatment at a remote location to ameliorate that adverse physiological condition. In this mode, theelectrode802 would sense the adverse condition and send an alternating electrical signal out fromelectrode801 to carry out some treatment at a remote location within the body. Theelectrode854 would receive that signal and could cause the sensor/actuator device850 to carry out a pre-programmed treatment. For example, if a migraine headache is perceived by thecontrol module820, the sensor/actuator device850 could be instructed to release medication via thecatheter853 into the cerebrospinal fluid (the CSF) to relieve that headache. Or a Parkinson's disease tremor might be detected and the neurotransmitter epinephrine would be appropriately released into the CSF to relieve that tremor. In another example, if the patient thought about moving a certain muscle that had been made inoperative due to interrupted nerve conduction, that muscle could be activated by theelectrode856 which is connected by thewire852 to the sensor/actuator device850.
• It should be understood that the communication signal means between the[0198]control module820 and the sensor/actuator device850 could be modulated by any one of several well known techniques (such as AM, FM, phase modulation, etc.) in order to carry out proportional responses based upon the sensing signal received by theelectrode802 and processed by thecontrol module820. It should also be understood that communication between thecontrol module820 and the remote sensor/actuator device850 could be accomplished by acoustic (e.g. ultrasonic) vibrations from a buzzer at either location to a microphone at the receiving end of the transmission or by any suitable electromagnetic communication means. Of course it is also understood that a multiplicity of electrodes could be used with either thecontrol module820 or the sensor/actuator device850, and that both thecontrol module820 and the remote sensor/actuator device850 might together produce the response to a detected event.
• It is further envisioned the signaling means between the[0199]control module820 and the remote sensor/actuator device850 may be in the form of either analog or digital signals.
• FIG. 23 also illustrates how a[0200]buzzer95 connected by thewires92 to acontrol module820 could be used as part of the means for stopping a neurological event such as an epileptic seizure. Since the buzzer could be located in close proximity to the ear, if it produces an acoustic output when an epileptic seizure is detected by thecontrol module820, that acoustic input into the brain can stop the epileptic seizure. Furthermore, a hearing aid type ofacoustic output device895 placed in the ear could have an acoustic output of a particular intensity and pitch that could turn off the seizure. The operation of either thebuzzer95 or theacoustic output device895 would be automatic, i.e., when a seizure precursor is detected, an acoustic input signal would be applied automatically. Thedevice895 could be actuated by receiving a signal from thebuzzer95.
• FIG. 23 also shows a visual[0201]light source896 that could be a light emitting diode in eyeglasses worn by the patient or a special flashlight type of device. Either device could be used with a particular wavelength of light and rate of flashing on and off so as to provide a visual input that could act as a means for stopping an epileptic seizure. Although thelight source896 could be automatic if it were on a pair of eyeglasses, if a flashlight type of device is used, the visual input would be manually applied.
• Also shown in FIG. 23 is a[0202]sensory actuator897 which can apply electrical stimulation toelectrodes898 throughwires899 to the patient's skin. Thesensory actuator897 might also produce mechanical vibrations applied directly to the patient's skin.
• FIG. 24 shows an alternative embodiment of the invention, which uses a multiple pin,[0203]pyrolytic carbon receptacle911 placed through the patient's scalp which provides a multiplicity of electrical connections for thecontrol module920. Specifically, thesystem900 has acontrol module920 that is electrically connected to thereceptacle911 by means of thewire cable922. Themating plug912 is connected by thecable913 to provide two-way communication via electrical wires between thecontrol module920 and theexternal equipment11. Theplug912 andcable913 can also be used with thecharging equipment914 to recharge a rechargeable battery (not shown) located in thecontrol module920.
• Also shown in FIG. 24 are other alternative means for providing two-way communication between the[0204]control module920 and theexternal equipment11. Specifically, FIG. 24 shows an acoustic (ultrasonic) transducer931 mounted on thecontrol module920 that can communicate with the externally locatedtransducer932 which is in two-way communication with theexternal equipment11 through thewire cable933. In a similar manner, an infrared emitter/receiver941 can send an infrared signal through the patient's scalp to an infrared emitter/receiver943 that is connected by thewire cable943 to theexternal equipment11.
• By any of these methods, either direct electrical connection, or acoustic or infrared two-way communication the equivalent function of[0205]element72 in FIG. 2 can be accomplished. It has already been established that two-way communication72 can also be accomplished by a variety of electromagnetic means including an alternating magnetic field or by radio frequency communication.
• FIG. 24 also shows other locations for electrodes that are to be placed in close proximity to the brain. Specifically, FIG. 24 shows an[0206]electrode950 mounted on the outer surface of the scalp that is connected by thecable wire951 to thecontrol module920. Such anexternal electrode950 could also be used with an externally placed control module (not shown). Additionally, electrodes such as theelectrode960 could be placed between the patient's scalp and cranium and would be connected by thewire cable961 to thecontrol module920. Furthermore, electrodes such as theelectrode950 could be placed between the dura mater and the arachnoid and would be connected via thewire cable971 to thecontrol module920.
• It should be noted that any of the electrodes described herein that are in the general proximity of the brain either inside or on top of the patient's head or deep within the patient's brain can all be considered to be “brain electrodes.”[0207]
• FIG. 25 illustrates a[0208]system980 for the treatment of neurological disorders that uses anexternal control module990 with either internal or external means for stopping a neurological event. Specifically, the scalp mountedelectrode994 connected by thewire996 to thecontrol module990 could be used to detect a neurological event. Of course one could use a multiplicity of such scalp-mounted electrodes. Once a neurological event has been detected, thecontrol module990 could actuate anacoustic input device895, or a visuallight input device986 or anactuator897 for other sensory inputs. Thus, such asystem980 envisions acontrol module990 mounted external to the patient that uses external remote actuators that can provide acoustic, visual or other sensory inputs that could stop an epileptic seizure.
• Furthermore, the[0209]system980 envisions the use of the externally mountedcontrol module990 with electrodes mounted in close proximity to the brain or actually within the brain (i.e. “brain electrodes”). Specifically, theelectrodes801 and802 could be mounted on the dura mater and adeep electrode801D could be placed within the brain itself. Thewires811,812 and811D could be connected to receptacle982 that is mated to theplug984 that connects by thewire992 to thecontrol module990. Theelectrodes801,802 and801D could be used either for sensing a neurological event or for providing an electrical stimulation to stop such a neurological event.
• In FIG. 25, the remote sensor/[0210]actuator device850 can be used as part of the means for stopping a neurological event by applying an electrical stimulus to one or two vagus nerves by means of theelectrodes854 and/or856. This could also be accomplished using the system shown in FIG. 23, i.e., with any control module820 (or20) that is implanted beneath the scalp. In FIG. 25 thecatheter853 can be used to apply medication as part of the means for stopping a neurological event. The sensor/actuator device850 can be triggered to stop the neurological event by means of a signal originating from the externally mountedcontrol module990.
• Also shown in FIG. 25 is an external[0211]remote actuator897 which can apply electrical stimulation toelectrodes898 throughwires899 to the patient's skin. Theactuator897 might also produce mechanical vibrations applied directly to the patient's skin as another form of sensory input.
• Additional objects and advantages of the present invention will become apparent to those skilled in the art to which this invention relates from the subsequent description of the preferred embodiments and the appended claims, taken in conjunction with the accompanying drawings.[0212]

Claims (20)

What is claimed is:

1. A system for treating a neurological disorder in a patient, the system comprising:

a control module adapted to be implanted in the patient, wherein the control module includes a data communication subsystem; and

external equipment comprising an external data interface and a physician's workstation connected to communicate through the external data interface;

wherein the data communication subsystem and the external data interface cooperatively enable a bi-directional communication data link between the control module and the external apparatus; and

wherein the physician's workstation is adapted to exchange data with the control module.

2. The system for treating a neurological disorder ofclaim 1, wherein the physician's workstation is adapted to retrieve EEG data from the control module.

3. The system for treating a neurological disorder ofclaim 2, wherein the physician's workstation is further adapted to display data representative of the EEG data.

4. The system for treating a neurological disorder ofclaim 1, wherein the control module is adapted to detect and store neurological events, and wherein the physician's workstation is further adapted to retrieve a history of detected neurological events from the control module.

5. The system for treating a neurological disorder ofclaim 4, wherein the physician's workstation is further adapted to display data representative of the history of detected neurological events.

6. The system for treating a neurological disorder ofclaim 1, wherein the physician's workstation is further adapted to transmit a programmable parameter to the control module.

7. The system for treating a neurological disorder ofclaim 1, wherein the physician's workstation is further adapted to transmit a software update to the control module.

8. The system for treating a neurological disorder ofclaim 1, wherein the data communication subsystem includes a first antenna comprising a first coil of wire and the external data interface includes a second antenna comprising a second coil of wire.

9. The system for treating a neurological disorder ofclaim 8, wherein the bi-directional communication data link comprises a wireless data link.

10. The system for treating a neurological disorder ofclaim 8, wherein the bi-directional communication data link comprises an RF data link.

11. The system for treating a neurological disorder ofclaim 8, wherein the bi-directional communication data link comprises an inductive data link.

12. The system for treating a neurological disorder ofclaim 1, wherein the physician's workstation is connected to the external data interface by a serial data link.

13. The system for treating a neurological disorder ofclaim 1, wherein the external data interface includes a first modem, the physician's workstation includes a second modem, and the physician's workstation is connected to the external data interface by a trans-telephonic data link.

14. The system for treating a neurological disorder ofclaim 13, physician's workstation is located at a position remote from the external data interface and the control module.

15. A system for treating a neurological disorder in a patient, the system comprising:

a control module adapted to be implanted in the patient, wherein the control module includes a data communication subsystem; and

external equipment comprising an external data interface and a patient's initiating device connected to communicate through the external data interface;

wherein the data communication subsystem and the external data interface cooperatively enable a data link from the external apparatus to the control module; and

wherein the patient's initiating device is adapted to receive a command from the patient and transmit a command signal representative of the command to the control module.

16. The system for treating a neurological disorder ofclaim 15, wherein the control module is programmed to perform an action in response to the command signal.

17. The system for treating a neurological disorder ofclaim 16, wherein the command indicates that the patient has perceived a neurological event, and wherein the action comprises initiating a therapeutic response to the neurological event perceived by the patient.

18. The system for treating a neurological disorder ofclaim 17, wherein the action comprises delivering an electrical stimulation signal to a brain of the patient.

19. The system for treating a neurological disorder ofclaim 15, wherein the action comprises storing EEG data in a buffer of the control module for later retrieval.

20. The system for treating a neurological disorder ofclaim 15, wherein the action comprises deactivating the control module.

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